Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Tablets (New Drug Application 209816)

Resumen

The Food and Drug Administration (FDA, the Agency, or we) has determined the regulatory review period for Nuzyra Tablets (new drug application (NDA) 209816) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.